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Petitioners/Plaintiffs-Appellants Cuc Thi Ngo, Angelo Nguyen, Anthony Nguyen, An Van Nguyen, and Leo Young, Esq., in his capacity as Personal Representative of the Estate of Jennifer Giao Nguyen, Deceased, (collectively, Plaintiffs) applied for writ of certiorari from the Intermediate Court of Appeals’s (ICA) February 11, 2014 Judgment on Appeal, entered pursuant to its December 30, 2013 Memorandum Opinion, which vacated and remanded the Circuit Court of the First Circuit’s July 28, 2009 Final Judgment.

This case arises from the death of a nine year old minor child (Minor) from cardiac arrest caused by hypovolemic shock, a condition in which the heart is unable to pump enough oxygen and nutrients to the tissues because of a severe loss of fluid. Before her death, Minor had been taken to the emergency room at the Queens Medical Center for vomiting and diarrhea. Dr. Thinh Nguyen (Defendant) intravenously administered fluid, saline, and an anti-emetic named Reglan. Defendant discharged Minor when Minor reported feeling better, and prescribed additional Reglan to take as needed. Minor continued to suffer from diarrhea and vomiting when she returned home. Two days later, Minor lost consciousness and died.

Plaintiffs sued in the Circuit Court of the First Circuit (circuit court), alleging, inter alia, that Defendant failed to adequately inform Plaintiffs of the nature and risks of treating Minor with Reglan. During trial, an expert in emergency room and pediatric medicine testified that he would never have prescribed Reglan to Minor because one of the side effects of Reglan, and other anti-emetics, is an increase in diarrhea. The expert testified that there were alternative anti-emetics that were specifically approved by the FDA in pediatric patients that had lower risks of side effects than Reglan. The expert also testified that the manufacturer’s insert for Reglan stated that the safety and effectiveness of Reglan had not been established for pediatric patients, and that the safety profile for Reglan in adults could not be extrapolated to pediatric patients. In addition, Plaintiffs’ expert in anatomic and clinical pathology testified that in his opinion, Reglan increased Minor’s diarrhea “quite significantly,” thereby increasing dehydration, and that this increase in dehydration was a substantial factor leading to Minor’s hypovolemic shock.

At the close of Plaintiffs’ case, Defendant moved for judgment as a matter of law (JMOL) on the issue of informed consent, arguing there must be expert testimony that establishes the “materiality of the risk.” The circuit court granted the motion, concluding that there was no legally cognizable claim for informed consent because there was no expert testimony on “materiality.” The circuit court concluded that, even viewing the Plaintiffs’ evidence and inferences in the light most favorable to Plaintiffs, a reasonable jury could not find in their favor.

The ICA affirmed, holding that Plaintiffs had failed to “prove the ‘materiality of the risk’ by ‘adducing expert medical testimony to establish the nature of the risks inherent in a particular treatment, the probabilities of therapeutic success, the frequency of the occurrence of particular risks, and the nature of available alternatives to treatment.’” The ICA concluded that Plaintiffs’ expert testimony (1) “did not sufficiently elaborate on the probabilities that Reglan treatment would be successful”; and (2) did not establish that the “risk in question” with Reglan was “so great” so as to satisfy Plaintiffs’ burden of establishing the frequency of the occurrence or the significance of that risk. In addition, the ICA concluded that “the manufacturer’s warning, in and of itself, does not establish the materiality of risk of harm with respect to Reglan, because it does not constitute ‘expert testimony’ and does not permit a legitimate inference regarding the materiality of that risk.” Finally, the ICA rejected Plaintiffs’ argument that Defendant had failed to inform Plaintiffs of a safer, alternative medicine as required by HRS § 671-3(b), holding that Plaintiffs had waived this claim by failing to raise it in circuit court.

Plaintiffs present the following questions on certiorari:

1. Whether it was error to exclude or discount evidence of information contained in a drug’s package insert or PDR entry, in combination with expert testimony as to the significance of that information, on a claim of informed consent.

2. Whether a physician’s admitted failure to disclose the information required by HRS § 671-3(b)(1) through (6), when coupled with evidence of the materiality of such failure, precludes a finding of informed consent.